| CTRI Number |
CTRI/2025/02/080980 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intravenous fluids] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the effect of intravenous administration of PlasmaLyte A versus Normal saline on serum chloride levels in children |
|
Scientific Title of Study
|
Plasma-Lyte-A versus Normal Saline for
intravenous fluid therapy in children: A
Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kamran Afzal |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, AMU |
| Address |
Department of Pediatrics,
Jawaharlal Nehru Medical College,
Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
05712721182 |
| Fax |
|
| Email |
drkafzal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamran Afzal |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Pediatrics,
Jawaharlal Nehru Medical College,
Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
05712721182 |
| Fax |
|
| Email |
drkafzal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshad P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Pediatrics,
Jawaharlal Nehru Medical College,
Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7034005601 |
| Fax |
|
| Email |
arshadpulikkal333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, AMU, Aligarh Uttar Pradesh, India, 202002 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Department of Pediatrics,
Jawaharlal Nehru Medical College, AMU,
Aligarh, Uttar Pradesh, India, 202002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kamran Afzal |
Jawaharlal Nehru Medical College |
(1) Pediatric Emergency, Second Floor, Emergency and Trauma Centre, Jawaharlal Nehru Medical College.
(2) Pediatric Intensive Care Unit, Jawaharlal Nehru Medical College, AMU, Aligarh
Aligarh
UTTAR PRADESH |
05712721182
drkafzal@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.), Jawaharlal Nehru Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, (2) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition, (3) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (4) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (5) ICD-10 Condition: K929||Disease of digestive system, unspecified, (6) ICD-10 Condition: Q209||Congenital malformation of cardiacchambers and connections, unspecified, (7) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline |
At the time of enrolment, baseline data will be recorded in a proforma. This will
include name, gender, diagnosis, any significant history, previous hospitalization,
disease severity score with Pelod-2 and baseline investigations like CBC, kidney
function test, or any other test deemed necessary for the treatment of the case.
Starting from the moment of randomization, the intravenous fluid therapy (IVF) for
enrolled patients must align with their allocated arm.
IVF encompasses both maintenance fluids and any potential bolus fluids
administered during the patient’s stay in the hospital.
Total parenteral nutrition and drug dilutions will not be considered as part of IVF.
If a patient was already receiving a different fluid at the time of randomization, the
protocol mandates a switch to the allocated fluid.
Any deviation from this protocol—such as providing an alternative study fluid or a
different fluid type (e.g., Albumin 4%)—will be recorded as a protocol violation.
RBS will be monitored 2 hourly during fluid therapy and/ or as clinically indicated.
Supplementation of dextrose and potassium will be done separately when required.
At the time of randomization, an arterial, venous, or capillary blood gas analysis will
be conducted. This analysis will measure pH, sodium, and chloride levels.
IV fluid therapy will be given for at least 48 hours following randomization.
Subsequently, these measurements will be repeated at 24 and 48 hours while
receiving intravenous fluid therapy (IVFT)
All other treatments, including electrolyte supplementation, medications, dextrose
infusion, colloid administration, and blood product transfusions, will adhere to the
local institutional procedures. Additionally, routine laboratory monitoring for children
receiving IVF—such as daily blood tests to assess organ function—will be carried
out as directed by the treating clinician. |
| Intervention |
Plasmalyte A |
At the time of enrolment, baseline data will be recorded in a proforma. This will
include name, gender, diagnosis, any significant history, previous hospitalization,
disease severity score with Pelod-2 and baseline investigations like CBC, kidney
function test, or any other test deemed necessary for the treatment of the case.
Starting from the moment of randomization, the intravenous fluid therapy (IVF) for
enrolled patients must align with their allocated arm.
IVF encompasses both maintenance fluids and any potential bolus fluids
administered during the patient’s stay in the hospital.
Total parenteral nutrition and drug dilutions will not be considered as part of IVF.
If a patient was already receiving a different fluid at the time of randomization, the
protocol mandates a switch to the allocated fluid.
Any deviation from this protocol—such as providing an alternative study fluid or a
different fluid type (e.g., Albumin 4%)—will be recorded as a protocol violation.
RBS will be monitored 2 hourly during fluid therapy and/ or as clinically indicated.
Supplementation of dextrose and potassium will be done separately when required.
At the time of randomization, an arterial, venous, or capillary blood gas analysis will
be conducted. This analysis will measure pH, sodium, and chloride levels.
IV fluid therapy will be given for at least 48 hours following randomization.
Subsequently, these measurements will be repeated at 24 and 48 hours while
receiving intravenous fluid therapy (IVFT)
All other treatments, including electrolyte supplementation, medications, dextrose
infusion, colloid administration, and blood product transfusions, will adhere to the
local institutional procedures. Additionally, routine laboratory monitoring for children
receiving IVF—such as daily blood tests to assess organ function—will be carried
out as directed by the treating clinician. |
|
|
Inclusion Criteria
|
| Age From |
0.50 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Admitted to PICU or emergency due to medical conditions.
2. Need for intravenous fluid administration
3. Serum sodium more than 130 mmol/L (measured on admission or no longer than 48 h before randomization)
|
|
| ExclusionCriteria |
| Details |
1. Pre-existing conditions like cardiac conditions and chronic kidney disease.
2. Disease-specific IVF protocols - Traumatic brain injury or at risk of cerebral edema, Burns, Post-liver transplant, post-renal transplant, Diabetic ketoacidosis, Oncology patients needing hyperhydration.
3. Blood sugar less than 60 mg/dl at the time of start of intervention and during 48 hours of intervention.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in serum chloride by at least 5 mmol/L |
At baseline and at the end of 48 hours from the beginning of the infusion of intervention/comparator agents |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. New-onset acute kidney injury (AKI).
2. Length of PICU stay
3. Length of hospital stay.
4. PICU-free survival.
|
New onset AKI within 48 hours of beginning of intervention/comparator agents |
|
|
Target Sample Size
|
Total Sample Size="438"
Sample Size from India="438"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial is designed to compare, in hospital setting, two isotonic fluids, i.e. Plasma-Lyte A and normal saline for intravenous fluid therapy in children. The primary outcome measure of the study is change in serum chloride level at 48 hours from baseline. Secondary outcome measures include new onset AKI, length of PICU stay, length of hospital stay and PICU-free survival. |